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Warning Letters Health Care Providers

Wiley Rein LLP

FTC Sends Warning Letters to 37 Eyeglass and Contact Lens Prescribers Over Possible Rule Violations

Wiley Rein LLP on

On June 3, 2025, the Federal Trade Commission (FTC) announced its staff had sent warning letters to 37 contact lens prescribers that, according to the FTC, were the subject of consumer complaints concerning possible...more

Holland & Knight LLP

American Hospital Assn. v. Becerra: Are Tracking Tools OK Again? Court Dials Back OCR Bulletin

Holland & Knight LLP on

A recent federal court decision is a victory for Health Insurance Portability and Accountability Act (HIPAA) covered entities using third-party tracking tools on unauthenticated webpages. These are websites available to the...more

Husch Blackwell LLP

CMS Imposes First Price Transparency Rule Penalties

Husch Blackwell LLP on

The Price Transparency Rule (the Rule) became effective on January 1, 2021. By October 2021, the Centers for Medicare & Medicaid Services (CMS) had issued warnings to over 300 hospitals deemed not in compliance with the...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 30, Number 28. News Briefs: August 2021

Report on Medicare Compliance 30, no. 28 (August 2, 2021) - CMS has not fined any hospitals yet for noncompliance with price transparency requirements, a spokesperson tells RMC. “In April 2021, CMS began issuing warning...more

Sheppard Mullin Richter & Hampton LLP

CMS Proposes Repeal of Certain Cost Reporting Requirements from the IPPS Final Rule for 2021

On April 27, 2021, the Centers for Medicare and Medicaid Services (“CMS”) released the Hospital Inpatient Prospective Payment System (“IPPS”) and Long-Term Care Hospital (“LTCH”) unpublished Proposed Rule for 2022 (“Proposed...more

K&L Gates LLP

COVID-19: FDA Warning Letters Address Fraudulent Products and Failures to Meet EUA Requirements

K&L Gates LLP on

In this week’s episode, Kenneth Kennedy discusses FDA’s ongoing focus on the issuance of warning letters to firms marketing fraudulent COVID-19 products, and to manufacturers who have failed to meet certain requirements under...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

Hogan Lovells

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate...

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On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more

Skadden, Arps, Slate, Meagher & Flom LLP

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

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